Performer G07919Recalls & reported problems
Cook Incorporated · Check-Flo Performer Introducer · Class 2
All models of Performer (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002079199), received between Apr 12, 2018 and Apr 27, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Damaged Prior to Use1
- Split1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2018Split; Split
IT WAS INITIALLY REPORTED THAT THE PERFORMER INTRODUCER WAS FOUND DAMAGED IN THE PACKAGE. THERE WAS NO PATIENT CONTACT. UPON RETURN OF THE DEVICE TO THE MANUFACTURER, A SPLIT WAS OBSERVED TO THE TIP, OR DISTAL END, OF THE COMPLAINT DEVICE.
Patient problems: No Patient Involvement
MAUDE report 7468680 ↗MalfunctionApr 12, 2018Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT THE GREY TIP OF THE RCFW-6.0-35-RB PERFORMER INTRODUCER WAS DAMAGED PRIOR TO REMOVAL FROM THE PACKAGE. IT WAS NOT USED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7425637 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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